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ANNEX A

I. HEMODIALYSIS
REVISED ACCREDITATION REQUIREMENTS
FOR FREESTANDING DIALYSIS CLINICS PROVIDING HEMODIALYSIS
1. It must be licensed by the Department of Health
2. It must be in operation for at least three years prior to accreditation.
3. It must comply at all times with the rules and regulations covering the licensure
and regulation of dialysis clinics consistent with E.O. 119, which states that the
Department of Health has the power to regulate the operation of and issue
licenses and permits to government and private clinics and dispensaries and other
such establishments which by nature of their functions are required to be regulated
by the Department.
4. It must have a Certificate of Accreditation of Dialysis Clinic by the Philippine Society
of Nephrology
5. It must have an ongoing Quality Assurance Program.
6. Payment of P5, 000.00 as accreditation fee.
STRUCTURE
I. Personnel
A. Medical Staff
Require CME units or continued trainings
Identify specific functions to delineate the specific roles that each personnel would
assume.
Director:
Executive
- may not be a medical doctor
Medical
- should be a medical doctor, attend to patients care
- to identify roles of Medical Director/Medical Unit
Head including their right to determine to decide/implement on what
is right for the patient
1.

Head
1.1
Must be a Diplomate of the Philippine Society of Nephrology Specialty Board
(PSNSB)
1.2
Must be accredited with PhilHealth
1.3
Must be a member of the National Health Insurance Program
1.4
May not necessarily be the Medical Director

2.

Other Medical Staff


2.1
Duty physicians must have completed prescribed years of training from an
accredited Internal Medicine training program.
2.1.1 Certification from the Chair of the training program on Basic Life Support
2.2
Attending physician must be certified by the Philippine Society of Nephrology
Specialty Board (PSNSB)
2.3
Must be accredited with PhilHealth
2.4
Must be members of the National Health Insurance Program
2.5
At least one should be a member of the medical staff of a tertiary hospital in
the locality to facilitate referral of complications that may arise from the dialysis
procedure

2.6

2.7

If the above is not possible, the clinic should have a memorandum of


agreement with tertiary hospital for complications that may arise from the
dialysis procedure. Ambulance service should be readily available for the
transport of the patients.
Duty physician to treatment station ratio 1:15

B. Other Staff
1.

Head Nurse
1.1
Must be certified by the Renal Nurses Association of the Philippines (ReNAP)
1.2
Must attend one postgraduate course on dialysis per year or equivalent
seminars in dialysis
1.3
Completed and certified IV therapy nurse
1.4
Licensed and with experience in hospital/ clinical work for one year
1.5
Advanced Life Support training-

2.

Other Nursing Staff


2.1
Certified by ReNAP
2.2
Completed and certified IV therapy nurse
2.3
Attends updates related to nursing staffs duty
2.4
Licensed and with experience in hospital/ clinical work for one year
2.5
Nurse patient ratio 1:4
2.6
Advance Life Support training
At least one Nurse per shift with BLSS training

3.

Dialysis technicians
3.1
Must have a certificate of dialysis training and at least one-year experience in
same field

4.

Midwives or nursing attendants (optional)


4.1
Must have finished a one-year course in nursing aide or attendant with two
years college studies

5.

Machine Technician &/or service maintenance agreement

6.

Administrative personnel

7.

Utility man

II. Physical Plant


A. Administrative Service
Accessibility of Hemodialysis Unit (Preferably should be in the ground floor with a
ramp for handicap patient. If the unit is in the second floor, elevator should be fully
functional)
1.

2.

Lobby
1.1
Information counter/ admitting room
1.2
Waiting area for pre-treatment patients.
1.3
Toilet facilities for the patients and their companions, space should be wide
enough to accommodate ramp and rail for handicaps.
Cashier/ billing / Business Center

3.
4.

Toilet facilities for the staff


Pantry/Multi function room for the staff/Workplace for Medical, Nursing and Clerical
Staff

B. Dialysis Service Complex


1.

2.
3.
4.
5
6.
7.
8.

Dialysis room with adequate ventilation


1.1
Dedicated machines for Hepatitis B and Hepatitis C patients
1.2
Separate space for reprocessing/separate reprocessing machines for Hep B and
Hep C if not available reprocessing should be done manually
1.2.1 For Hepatitis B dialysis patients
1.2.2 For Hepatitis C dialysis patients
1.2.3 For regular patients (non-A, non-B, non-C)
Doctors clinic
Nurses Station
Lavatory
4.1
One separate for Hep B, Hep C
4.2
Regular patients 1:6 ratio
Sterile instrument supply and storage area, additional space for storage of re-processed
dialyzers
Toilet facility already mentioned previously
Releasing area for post hemodialysis patients
Sterilization and supply room

III. Facilities
A. Water Treatment System
1.

Quality of water treatment system should include the following:


1.1
1.2
1.3
1.4
1.5
1.6

2.

3.

Multi-media
Water softener
Carbon filter
Reverse osmosis (RO) system
Deionizer (optional)
Storage tank for RO and a post ultraviolet sterilization, post RO treatment
followed by a micro filter
Monitoring requirements:
2.1
Chemical analysis - prior to initial licensing by DOH then at least six months
send to an accredited laboratory by DOST or by any accrediting body. Specify
the substances to be tested and the recommended values according to AAMI.
2.2
Bacteriologic analysis- to be checked monthly of all post RO. Disinfection by
either chemical or heat may vary according to the type of water treatment.
2.1.1. Raw water testing pre and post
2.3
Technical checking of pressure gauge, daily monitoring, and logging of flow
rates.
Treated water must meet the recommended standard of Association of Advancement
of Medical Instrumentation (AAMI)
3.1
RO water to prepare dialysate, reprocessing and rinsing, dialyzer disinfectant
(less than 200 colonies cfu/cc)
3.2
Dialysate water (less than 200 colonies/cc)

IV. Equipment/ Instruments/ Supplies / Vehicles


1.

2.
3.
4.
5.
6.
7.
8.
9.

10.

Dialysis machine
1.1.
Machine must have certain features like temperature and Ultrafiltration (UF)
control at least not more than 30,000 hours of use of equivalent or not more
than ten years or whichever comes first.
1.2.
Ratio of machines to population: one (1) machine for every 7-8 patients
1.3.
Availability of bicarbonate dialysis and biocompatible membranes
1.4.
Dedicated machines for Hepatitis B patients
1.5.
Dedicated machines for Hepatitis C patients
1.6.
Back up machines:
1.6.1 One (1) back-up machine for every 15 machines. If center has less
than fifteen (15) machines, it should have
at least one (1) back-up machine.
Dialysis center should not be running beyond 75% of capacity
1.6.2 One (1) back-up machine for Hepatitis B patient
1.7. Separate reprocessing machine and/or manual reprocessing. If there is only one
reprocessing machine, the Hep B and Hep C shall be reprocessed manually.
1.7.1 For regular patients
1.7.2 for Hepatitis B dialysis patients
1.7.3 for Hepatitis C dialysis patients
Properly labeled stethoscope one for Hep B, Hep C and regular patients
Properly labeled sphygmomanometer with stand one for Hep B, Hep C and regular
patients
Examining light
Oxygen unit with gauges (1:4 ratio)
Minor surgical instrument set
Instrument table
Patients dialysis chairs or bed(s) with guardrails
E cart with emergency medicines
9.1.
Dopamanine IV infusion
9.2.
Isosorbide dinitrate tablets
9.3.
Diazepam (tablets and IV)
9.4.
Hydrocortisone IV
9.5.
Diphenhydramine maleate 50mg/amp
9.6.
Sodium chloride 20% in 50cc polyampule
9.7.
D50W 50cc vial
9.8.
Parenteral antihypertensive medications
9.9.
Clonidine
9.10. Furosemide IV
9.11. Calcium Gluconate
9.12. Epinephrine
9.13. Lidocaine
9.14. Salbutamol(nebule)
9.15. Nifedipine
9.16. Sodium Bicarbonate
9.17. Atropine Sulfate
9.18. Endotracheal tube with guide wire
9.19. Laryngoscope with functional bulbs and batteries
9.20. Ambubag
Nebulizer

11.
12.
13.
14.
15.
16.
18.
19.
20.
21.
22.

Goose neck lamp


Stand-by rechargeable light
Sterilizer
ECG machine
Suction machine
Cardiac monitor
Defibrillator
Stretcher
Wheelchair
Acceptable disinfectants for re-use procedures:
21.1 Formalin (4%)
21.2 Peracetic Acid (Hydrogen peroxide = Acetic acid)
Others:
22.1. Standby generator
22.2. Fire extinguisher
22.3. Transport vehicle for patients use (ambulance) or a contract with providers of
such ambulance services

V. Records
1.

Dialysis charts
1.1
Standing order for hemodialysis (updated)
1.2
Physicians order
1.3
Consent Form
1.4
Patients monitoring sheet
1.5
Standing order for medications
1.6
Tabulation of laboratories
1.7
Complications during dialysis
1.8
Confinements and corresponding dates and hospital
1.9
History with P.E.
1.10 Problem list
1.11 Optional if transferred or referred-transfer/referral slip

2.

Logbooks
2.1
for complications related to hemodialysis procedure
2.2
for complications related to vascular access
1.3
for complications related to disease process (To be filled up by the medical
staff)
2.4
for dialysis adequacy of each patient
2.5
for outcomes
2.6
Hepatitis status logbook for patient/staff
2.7
Vaccination (Pneumonia, Flu and Hepatitis) logbook for patient/staff
2.8
For list of all patients accepted for dialysis
PROCESS

1.
2.

Universal precaution should be strictly observed (c/o Nurses Guidelines of Clinical


Practice)
Patient Health Maintenance
2.1
Laboratory Monitoring
2.1.1 Monthly chemistries to include:
2.1.1.1 Complete Blood Count

2.1.2
2.1.3
2.1.4
2.1.5
2.1.6

3.

4.
5.

2.1.1.2 Blood Urea Nitrogen


2.1.1.3 Serum Creatinine
2.1.1.4 Ionized Calcium
2.1.1.5 Inorganic Phosphorus
2.1.1.6 Potassium
2.1.1.7 SGPT for Hep C(+) and the population at risk for development of
Hepatitis B and C
Serum Albumin to assess nutrition every two (2) months
Hepatitis B and Hepatitis C every 6 months (determination for non-B, non-C
patients)
On HBSAg(-) and/or Ab(-) and HCV(-)
Monthly Urea Reduction Ratio and/ or KTV for Dialysis Adequacy
On all patients on 3x a week dialysis
Lipid profile every 6 months
Chest X-ray every 6 months

2.2
Disease prevention Vaccinations
2.2.1 Hepatitis B (double dose) at 0, 1, 2, 6 months
2.2.2 Influenza Annually
2.2.3 Pnuemococcal every 5 years
Dialysis Clinic Monitoring
3.1
The clinic should have written policies on:
3.1.1 Standard Operating Procedures that include
3.1.1.1 Dialysis from initiation to termination
3.1.1.2 Cleaning of machines and Disinfection procedure
3.1.1.3 Reprocessing
3.1.1.4 Access care
3.1.1.5 Femoral Cannulation (for emergency only)
3.1.1.6 Removal of Internal Jugular (IJ) and Subclavian Catheter
3.1.2 Management of Complications during Hemodialysis
3.1.2.1 Hypotension
3.1.2.2 Chills
3.1.2.3 Chest pains
3.1.2.4 Seizures
3.1.2.5 Cramps
3.1.2.6 Others
3.2
There should be a monthly in-house seminar for non-physician personnel staff
There should be a record of Preventive Maintenance Program for machines and water
treatment system once a year.
The clinic shall follow the prescribed Standards and Guidelines of Care as adapted
from the American Nephrology Nurses Association Universal Hemodialysis Guideline
for Care

ANNEX B
Revisions made on the Accreditation Requirements for Freestanding Dialysis Clinics
Offering Hemodialysis
FROM
TO
SPECIFIC ACCREDITATION REQUIREMENTS FOR DIALYSIS CLINICS
4. It must have a Certificate of
Acknowledgement of existence of
Dialysis Clinic by the Philippine Society of
Nephrology

4. It must have a Certificate of Accreditation of Dialysis


Clinics by the Philippine Society of Nephrology.

ACCREDITATION STANDARDS FOR DIALYSIS CLINICS


STRUCTURE
I. Personnel
A. Medical Staff

1. Head
1.1 Must be a Diplomate of the
Philippine Society of Nephrology
Specialty Board (PSNB)
1.2 Must be accredited with PhilHealth
1.3 Must be a member of the National
Health Insurance Program
2. Other Medical Staff
2.1 Duty physicians must have completed
prescribed years of training from an
accredited Internal Medicine training
program.
2.2 Attending and referring physician must
be Philippine Society of Nephrology
Specialty Board (PSNSB) certified

added the following:


Require CME units or continued trainings
Identify specific functions to delineate the specific roles
that each personnel would assume
Director:
The Executive Director may not be a medical doctor.
The Medical Director should be a medical doctor and
attends to patients care; to identify roles of Medical
Director/Medical Unit Head including their right to
determine to decide/implement on what is right for
the patient.

(added) Item 1.4 May not necessarily be the Medical


Director
2.1 Duty physicians must have completed prescribed years of
training from an accredited Internal Medicine training program.
(added) Item # 2.1.1 Certification from the Chair of the
Training program on Basic Life Support
2.2 Attending physician must be certified by the Philippine
Society of Nephrology Specialty Board (PSNB)
(added) Item # 2.7 Duty physician to treatment station ratio
1:15

B. Other Staff
1. Head Nurse
2. Other Nursing Staff
2.5 Nurse patient ratio 1:4
3. Medical Technician
4. Midwives or nursing attendants
5. Machine Technician
II. PHYSICAL PLANT
A. Administrative Service

(added) item 1.5 Advanced Life Support training


2.5 Nurse patient ratio 1:4
(added)item 2.6 For all Nurses: Advance Life Support
Training
At least one Nurse per shift with BLSS training
3. Dialysis technicians
4. Midwives or nursing attendants (optional)
5. Machine Technician &/or service maintenance agreement
A. Administrative Service
(added) Accessibility of Hemodialysis Unit (preferably
should be in the ground floor with a ramp for handicap

FROM

TO
patient). If the unit is in the second floor, elevator should
be fully functional

1. Lobby
1.1 Information counter/ admitting room
1.2 Communication Area

1. Lobby
1.1 Information counter/ admitting room
item #1.2 removed

1.3 Waiting Area

Item #1.3 changed to Item #1.2 Waiting Area for pretreatment patients

1.4 Toilet facilities

Item # 1.4 changed to item #1.3 Toilet facilities for patients &
their companions, space should be wide enough to
accommodate ramp and rail for handicaps

2. Cashier/Billing

2. Cashier/Billing/Business Center

2.1 Finance/budget Auditor


3. Toilet Facilities

B. Dialysis Service Complex


1. Dialysis room
1.1 Separate spaces for Hepatitis B
and Hepatitis C patients
1.2 Separate space for reprocessing

1.2 3 For regular patients


2. Nursing Area
3. Lavatory

item # 2.1 removed


3. Toilet Facilities for the staff
(added) item 4. Pantry/Multi function room for the
staff/Workplace for Medical, Nursing and Clerical Staff
1. Dialysis room with adequate ventilation
1.1 Dedicated machines for Hepatitis B & C patients
1.2 Separate space for reprocessing/separate reprocessing
machines for Hep B and Hep C if not available
reprocessing should be done manually
1.2 3 For regular patients (non-A, non-B, non-C)
item #2 changed to Doctors Clinic
Item # 3 changed to Nurses Station
4. Lavatory
( added) items 4.1 & 4.2)
4.1 One separate for Hep B, Hep C
4.2 Regular patients 1:6 ratio

4. Sterile instrument supply and storage


area
5. Sub-sterilizing room
6. Toilet Facility

Item #4 changed to Item #5 Sterile instrument supply and


storage area, additional space for storage of re-processed
dialyzers
item #5 removed
6. Toilet facility already mentioned previously

7. Receiving and releasing area

7. Releasing area for post hemodialysis patients

8. Central sterilization and supply room


9. Sterilizing and work area
10. Sterile supply storage area
III. FACILITIES
A. Water Treatment System
1. Quality of water treatment system should
include the following facilities:

8. Sterilization and supply room


item #9 removed
item #10 removed

1.5 Deionizer and ultraviolet

1. Quality of water treatment system should include the


following:
1.5 Deionizer (optional)

FROM

TO

sterilization

(added)
Item # 1.6 Storage tank for Reverse Osmosis (RO) and a
post ultraviolet sterilization, post RO treatment followed
by a micro filter.

2. Monitoring Requirements
2.1 Chemical- prior to every licensing by
DOH

2. Monitoring requirements:
2.1Chemical analysis- prior to initial licensing by DOH then
at least every six months sent to an accredited laboratory
by DOST or by any accrediting body. Specify the
substances to be tested and the recommended values
according to Association of Advancement of Medical
Instrumentation (AAMI).

2.2 Bacteriologic- to be checked


quarterly and after cluster incidents

2.2 Bacteriologic analysis- to be checked monthly of all post


RO. Disinfection by either chemical or heat may vary
according to the type of water treatment.
( added )item #s:
2.1.1 Raw water testing pre and post
2.3 Technical checking of pressure gauge, daily
monitoring and logging of flow rates

3. Treated water follows the Association


of Advancement of Medical
Instrumentation (AAMI)
Recommendations:
3.1 Reverse Osmosis water to prepare
dialysate, reprocessing and rinsing, dialyzer
disinfectant (less than 200 colonies/cc)
3.2 Dialysate water (less than 2,000
colonies/cc)
IV. Equipment/ Instruments/ Supplies
/ Vehicles
1. Dialysis machine
1.1 Machine should not be older than 10
years

1.5. Dedicated machines for Hepatitis C


patients (optional)
1.6. Back-up machines:
1.6.1
One (1) back-up machine for
every 15 machines

1.7. Separate reprocessing machine


and/or manual reprocessing
2. Stethoscope

3. Treated water must meet the recommended standards of


AAMI.

3.1 RO water to prepare dialysate, reprocessing and rinsing,


dialyzer disinfectant (less than 200 colonies cfu/cc)
3.2 Dialysate water (less than 200 colonies/cc)

1.1 Machines must have certain features like temperature


and Ultrafiltration (UF) control at least not more than
30,000 hours of use of equivalent or not more than ten
years or whichever comes first.
1.5 optional in item # 5 removed
1.6 Back up machines:
1.6.1 One (1) back-up machine for every 15 machines. If
center has less than fifteen (15) machines, it should at least
have one (1) back-up machine
( added)
Dialysis center should not be running beyond 75% of
capacity
(added)
item # 1.6.2 One (1) back-up machine for Hepatitis B
patient
1.7. Separate reprocessing machine and/or manual reprocessing.
If there is only one reprocessing machine the Hep B and
Hep C shall be reprocessed manually.
2. Stethoscope properly labeled one for Hep B, Hep C and
regular patients

FROM

TO

3. Sphygmomanometer with stand

3. Properly labeled sphygmomanometer with stand one for


Hep B, Hep C, and regular patients

5. Oxygen unit with gauge

5. Oxygen unit with gauge (1:4 ratio)

8. Treatment table

Item #8 removed

9. Patients bed(s) with guard rails

Item # 9 changed to item #8 Patients dialysis chairs or


bed(s) with guardrails

10. E cart with emergency medicines

Item # 10 changed to Item # 9 E cart with emergency medicines

10.9.

Others

Item # 10.9 changed to Item # 9.9 Clonidine


(added ) item #s:
9.10 Furosemide IV
9.11 Calcium Gluconate
9.12 Epinephrine
9.13 Lidocaine
9.14 Salbutamol (nebule)
9.15 Nifedipine
9.16 Sodium Bicarbonate
9.17 Atropine Sulfate
9.18 Endotracheal tube with guide wire
9.20 Laryngoscope with functional bulbs and batteries
9.21 Ambubag
(added) Item # 10 Nebulizer

V. Records
1.
Dialysis charts
1.1 Standing order for hemodialysis
1.2 Physicians order
1.3 Patients monitoring sheet
1.4 Standing order for medications
1.5 Tabulation of laboratories
1.6 Complications during dialysis

2. Logbooks
2.3 for complications related to disease
process

1.1 Standing order for hemodialysis (updated)


1.2 Physicians order
(added )item#1.3 Consent Form
Item 1.3 changed to item 1.4
Item 1.4 changed to item 1.5
Item 1.5 changed to item 1.6
Item 1.6 changed to item 1.7
(added) Item #s:
1.9 History with P.E.
1.10 Problem List
1.11 Optional if transferred or referral-transfer/referral slip

2.3 for complications related to hemodialysis procedure (to be


filled up by the medical staff)
(added) item #s:
2.6 Hepatitis status logbook for patient/staff
2.7 Vaccination (Pneumonia, Flu & Hepatitis)
logbook for patient/staff
2.8 For list of all patients accepted for dialysis

FROM
PROCESS
1. Universal precaution should be strictly
observed
2. Patient Monitoring (long term)
2.1

Monthly chemistries to include:


2.1.1 Complete Blood Count
2.1.2 Blood Urea Nitrogen
2.1.3 Serum Creatinine
2.1.4 Ionized Calcium
2.1.5 Inorganic Phosphorus

2.2 Serum Albumin to assess nutrition


every two (2) months
2.3 Hepatitis B and Hepatitis C every
6 months (determination for non-B, non-C
patients)

TO
1. Universal precaution should be strictly observed (c/o Nurses
Guidelines of Clinical Practice)
Item #2 changed to Patient Health Maintenance
Item 2.1 changed to Laboratory Monitoring
Item # 2.1.1 changed to Monthly chemistries to include:
Item # 2.1.2 changed to 2.1.1.1 Complete Blood Count
Item # 2.1.3 changed to 2.1.1.2 Blood Urea Nitrogen
Item # 2.1.4 changed to 2.1.1.3 Serum Creatinine
Item # 2.1.5 changed to 2.1.1.4 Ionized Calcium
2.1.1.5 Inorganic Phosphorus

(added) item #s:


2.1.1.6 Potassium
2.1.1.7 SGPT for Hep C (+) and the population at risk for
development of Hepatitis B and C
Item #2.2 changed to 2.1.2 Serum Albumin to assess nutrition
every two (2) months
Item # 2.3 changed to 2.1.3 Hepatitis B and Hepatitis C every 6
months (determination for non-B, non-C patients)

2.4

Monthly Urea Reduction Ratio


and/ or KTV for Dialysis
Adequacy

Item # 2.4 changed to 2.1.4 Monthly Urea Reduction Ratio


and/ or KTV for Dialysis Adequacy on all patients on 3x a week
dialysis

2.5

Lipid profile every 6 months

Item # 2.5 changed to 2.1.5 Lipid profile every 6 months


(added) item # 2.1.6 Chest x-ray every 6 months
(added)
2.2
2.2.1.
2.2.2
2.2.3

item #s:
Disease Prevention Vaccinations
Hepatitis B (double dose) at 0, 1,2, 6 months
Influenza Annually
Pnuemococcal every 5 years

3. Dialysis Clinic Monitoring


3.1

The clinic should have policies on:

3.1.1

Procedures

3.1.2

Management of Complications
during Hemodialysis

3.1.2.4 Others

3.1 The clinic should have written policies on:


Item 3.1.1 changed to Standard Operating procedures that
include
(added) item #s:
3.1.1.1 Dialysis from initiation to termination
3.1.1.2 Cleaning of machines and Disinfection procedure
3.1.1.3 Reprocessing
3.1.1.4 Access care
3.1.1.5 Femoral Cannulation (for emergency only)
3.1.1.6 Removal of Internal Jugular (IJ) and Subclavian
Catheter
3.1.2

Management of Complications during Hemodialysis

Item # 3.1.2.4 changed to Seizures


(added) Item #s:

FROM

TO
3.1.2.5 Cramps
3.1.2.6 Others

4. There should be a Preventive


Maintenance Program for machines and
water treatment system

4. There should be a record of Preventive Maintenance


Program for machines and water treatment system once a year.

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